POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs

Primary Outcomes

Measure

Recurrence Free Survival (RFS)

time frame:
362 events

Secondary Outcomes

Measure

Overall Survival (OS)

time frame:
472 events

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria:
- Histologically confirmed Stage IIb, IIc, III melanoma
- Surgical resection within 90 days of first dosing
- Persons with positive sentinel nodes must have a complete lymphadenectomy
- ECOG performance status 0 or 1
Exclusion Criteria:
- Any prior melanoma treatment other than surgery or regional irradiation
- Diagnosis of non-cutaneous melanoma or melanoma with unknown primary origin
- Use of biologic response modifiers within 60 days of first dosing
- Subjects with history of other malignancy within past 5 years (with exceptions)

Additional Information

Official title

A Multicenter, Double-blind, Placebo-controlled, Adaptive Phase 3 Trial of POL-103A Polyvalent Melanoma Vaccine in Post-resection Melanoma Patients With a High Risk of Recurrence